San Carlos, Calif.-based BioCardia said it converted all outstanding convertible promissory notes into shares of common stock before the merger, putting approximately $25 million in cash in their packets before the payment of fees and expenses for the merger.
“We are very pleased to complete this merger, which marks a significant milestone for BioCardia. We are transitioning from a private company to a publicly-traded company through this merger, and significantly increasing our financial resources. These funds are expected to support operations and enable us to advance our pivotal Phase 3 CardiAMP cell therapy program for the treatment of heart failure developed after a heart attack,” BioCardia prez & CEO Dr. Peter Altman said in a prepared release.
The new company will keep the development program for its CardiAMP cell therapy for heart failure patient’s who’ve had a heart attack. Stem cells derived from the bone marrow of patients likely to respond to the therapy, as indicated by testing for BioCardia’s biomarker, are delivered at a high dose using the Helix catheter.
The company’s cash-on-hand is slated to be used for a Phase III trial for CardiAMP, for which BioCardia said it already has an investigational device exemption from the FDA. The Centers for Medicare & Medicaid also approved the IDE for reimbursement, the company said.
The 250-patient, sham-controlled trial’s primary efficacy endpoint is change in 6-minute walking distance at 12 months. Safety outcomes include overall survival, freedom from major adverse cardiac events, time to 1st MACE and death from heart failure at 1 year. Other safety outcomes include survival at 2 years, serious adverse events at 30 days, plus heart failure hospitalization, all-cause hospitalization, days alive out of hospital, freedom from serious adverse events and New York Heart Assn. functional class, all at 12 months, according to ClinicalTrials.gov.
BioCardia said data from the trial are slated for review by the FDA’s Center for Biologics Evaluation & Research using the pre-market approval protocol.